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Smartwatch Monitoring for Leptomeningeal Metastasis

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Overseen ByAndrew Dhawan, MD, DPhil
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
Disqualifiers: Life expectancy <4 weeks, Severe dermatologic conditions, Severe cognitive impairment, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is for participants diagnosed with leptomeningeal metastasis disease (LMM), a condition where cancer has spread to the fluid and membranes surround the brain and spinal cord. The purpose of this study is to find out whether a consumer Smartwatch can continuously monitor the participant's health and detect early signs of neurological decline and whether sending an automatic alert to the participant's doctor when a change is detected can help reduce the number of participant hospitalizations.

Who Is on the Research Team?

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Andrew Dhawan, MD, DPhil

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people diagnosed with leptomeningeal metastasis, which means their cancer has spread to the fluid and membranes around the brain and spinal cord. Participants should be able to use a smartwatch and follow study instructions.

Inclusion Criteria

I am 18 years old or older.
Participants must have access to a compatible smartphone: iPhone running iOS 16 or higher and willingness to wear Apple Watch ≥10 hours/day; OR Android smartphone compatible with the study application and willingness to wear Samsung Galaxy Watch ≥10 hours/day
I have been diagnosed with leptomeningeal metastasis from any type of cancer.
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Exclusion Criteria

I am unable to give consent myself due to language or cognitive issues, but I have a legal representative who can help.
Anticipated life expectancy <4 weeks at time of screening per the treating physician
Inability to adhere to study procedures after training as assessed by the study team at enrollment
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Calibration Phase

Smartwatches are used to continuously capture data such as gait stability, heart rate variability, step count, and sleep to detect early signs of neurological decline

2-4 months

Stepped Wedge Intervention Phase

Participants cross-over to the intervention phase where automatic alerts are sent to doctors when changes are detected to reduce hospitalizations

3-4 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention phase

6 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests if using a consumer smartwatch to monitor health in real time can spot early neurological problems. If issues are detected, an automatic alert is sent to the doctor. The goal is to see if this reduces hospitalizations.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: C - Crossover at month 4Experimental Treatment2 Interventions
Group II: B - Crossover at month 3Experimental Treatment2 Interventions
Group III: A - Crossover at month 2Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

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